pain
Conditions
Interventions
Investigational drug group 1:FZ002-037 capsule 20 mg
placebo 1:placebo
Investigational drug group 2:FZ002-037 capsule 40 mg
placebo 2:placebo
Investigational drug group 3:FZ002-037 capsule 100 mg
placebo 3:placebo
Investigational drug group 4:FZ002-037 capsule 200 mg
placebo 4:Placebo
Investigational drug group 5:FZ002-037 capsule 400 mg
Placebo 5:Placebo
Investigational drug group 6:FZ002-037 capsule 600 mg
Placebo 6:Placebo
Investigational drug group 7:FZ002-037 capsule 800 mg
Placebo 7:Placebo
food effect study:FZ002-037 capsule 200 mg
MAD Investigational drug group 1:FZ002-037 capsule 200 mg
MAD Placebo group 1:Placebo 200 mg
MAD Investigational drug group 2:FZ002-037 capsule 400mg
MAD Placebo group 2:Placebo 400 mg
MAD Investigational drug group 3:FZ002-037 capsule 600 mg
Sponsors
Pearl River Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. The subjects need sign an informed consent form, fully understand the content and process of the trial as well as the potential adverse reactions, and indicate the date of signing; 2. Healthy Chinese male or female subjects aged 18 to 50 years old (including 18 and 50 years old); 3. Weight: male subjects = 50 kg, female subjects = 45 kg; body mass index (BMI) between 19.0 and 28.0 kg/m2 (including 19.0 and 28.0); 4. The subjects must agree to comply with the prescribed contraceptive requirements during the trial period and within 3 months after the last dose; 5. The subjects must be in good general health (evaluated by the investigator through medical history, surgical history, complete physical examination, vital signs measurement, laboratory tests, and 12-lead electrocardiogram results) with no evidence of active or chronic disease; 6. The subjects must be willing to understand and comply with the study procedures and restrictions, capable of completing the trial according to the plan, and able to communicate effectively with the investigators.
Exclusion criteria
Exclusion criteria: 1. Those who have special dietary requirements and cannot follow a unified diet; 2. Pregnant or lactating women, or women who have pregnancy plans during the test or within 3 months after the test, or women of childbearing age who have unprotected sex within 14 days before the first dose, or screening period or baseline serum women with a positive pregnancy test; 3. Those with a history of febrile illness or evidence of active infection within 14 days before the first administration of the study drug; 4. Subjects who received the new crown vaccine within 1 month before the first dose, or had a vaccination plan within 1 month after the start of the study; 5. Have a history of drug abuse or drug use, or have a positive urine drug screening result during the screening period or baseline period; 6. Drinking more than 14 units of alcohol per week within 3 months before signing the informed consent (1 unit = 360 mL beer with 5% alcohol, or 45 mL spirits with 40% alcohol, or 150 mL alcohol with 12% Wine), or those who had a positive alcohol breath test the day before the administration (breath alcohol content > 0.0 mg/100mL), or those who could not abstain from alcohol during the test; 7. Excessive use of nicotine products within 3 months before screening (the average daily smoking volume is more than 5); or those who do not agree to stop smoking during the test period or have a positive nicotine/cotinine test during the screening period; 8. Those who have eaten a diet containing grapefruit, grapefruit, caffeine, alcohol, etc. within 48 hours before the first administration, or who do not agree to prohibit the intake of the above diet during the test; 9. Have participated in this trial before, or participated in any other clinical trials within 30 days before the start of the trial, or plan to participate in other trials during the trial; 10. Positive infectious disease screening results during the screening period or baseline period, including detection of hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, HIV antibody and Treponema pallidum antibody; 11. Those who donate blood or lose a large amount of blood >= 400 ml within 3 months before the first administration, accept blood transfusion or use blood products, or plan to donate blood during the trial period or within 30 days after the last administration; 12. Use any drug that the investigator believes may affect the evaluation of the pharmacokinetic characteristics of the study drug (including prescription drugs, non-prescription drugs, Chinese herbal medicines, functional vitamins, health products, etc.) within 14 days before the first administration; 12. Before the first administration Within 14 days, any drug that the investigator believes may affect the evaluation of the pharmacokinetic characteristics of the study drug (including prescription drugs, non-prescription drugs, Chinese herbal medicines, functional vitamins, health products, etc.); 13. Clinical examination items such as physical examination, vital sign measurement, chest X-ray (front view), electrocardiogram measurement and any abnormal laboratory test results judged by the investigator to be abnormal with clinical significance; 14. Abnormal renal function (use the Chronic Kidney Disease EpidemiologyCollaboration [CKD-EPI] equation to calculate the glomerular filtration rate < 90 mL/min/1.73m2, see Appendix 1 for the formula: CKD-EPI formula); 15. There is a history of QTc interval prolongation in the past,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and safety endpoints (recording of adverse events, medical review and targeted examination, laboratory tests, and vital signs.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter; | — |
Countries
China
Contacts
Public ContactShuai He
Phase 1 Clinical Center, Zhujiang Hospital of Southern Medical University
Outcome results
None listed